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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01506895




Registration number
NCT01506895
Ethics application status
Date submitted
21/12/2011
Date registered
10/01/2012
Date last updated
21/11/2016

Titles & IDs
Public title
A Phase 2 Clinical Study to Investigate Effects of Darapladib in Subjects With Diabetic Macular Edema
Scientific title
A Phase 2, Multi-national, Multi-centre, Double Masked, Randomised, Placebo Controlled, Parallel-group Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Darapladib Administered for 3 Months to Adult Subjects With Diabetic Macular Edema With Centre Involvement
Secondary ID [1] 0 0
115403
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Retinopathy, Diabetic 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - darapladib
Treatment: Drugs - placebo

Experimental: darapladib - darapladib dosed at 160 mg once daily

Placebo comparator: placebo - Placebo to match once daily


Treatment: Drugs: darapladib
Experimental compound 160 mg dose

Treatment: Drugs: placebo
Placebo to match
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in Visual Acuity as measured by ETDRS BCVA
Timepoint [1] 0 0
3 months
Primary outcome [2] 0 0
Change from baseline in Spectral Domain Optical Coherance Tomography
Timepoint [2] 0 0
3 months
Secondary outcome [1] 0 0
Changes in Retinal Anatomy
Timepoint [1] 0 0
3 months
Secondary outcome [2] 0 0
Safety and Tolerability as assessed by change from baseline in outcome measures
Timepoint [2] 0 0
3 months
Secondary outcome [3] 0 0
Changes in Pharmacodynamic LP-PLA2 enzyme inhibition
Timepoint [3] 0 0
3 months
Secondary outcome [4] 0 0
Peak plasma concentration (Cmax) of study drug
Timepoint [4] 0 0
3 months
Secondary outcome [5] 0 0
Plasma concentration versus time curve (AUC) of study drug
Timepoint [5] 0 0
3 months

Eligibility
Key inclusion criteria
* A female subject is eligible to participate if she is of: Non-childbearing potential or child-bearing potential and agrees to contraception for an appropriate period of time
* Diagnosis of diabetes mellitus (type 1 or type 2)
* Confirmation of DME in the study eye by angiography
* Confirmation of retinal thickening in the study eye by study doctor
* Best corrected visual acuity score of 78-24 letters in the study eye
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Additional eye disease in the study eye that could compromise study assessments
* Intraocular surgery, or laser photocoagulation in the study eye within 3 months of dosing
* Uncontrolled intraocular pressure in the study eye despite treatment with glaucoma medication
* Uncontrolled diabetes
* Certain types of liver disease
* Severe reduction in kidney function OR removal of a kidney OR kidney transplant
* Blood pressure higher than normal despite lifestyle changes and treatment with medications
* Certain medications that may interfere with the study medication or eye assessments (these will be identified by the study doctor)
* Current severe heart failure
* Severe asthma that is poorly controlled with medication
* Previous severe allergic reaction to food, medications, drink, insect stings, etc
* If both birth parents are at least 50% Japanese, Chinese, or Korean ancestry, must have a blood sample collected for Lp-PLA2 activity. Those with Lp-PLA2 activity less than or equal to 20.0 nmol/min/mL are excluded
* Recent participation in a study of an investigational medication
* Any other reason the investigator deems the subject should not participate in the study
* Other protocol-defined inclusion/exclusion criteria may apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2013
Sample size
Target
Accrual to date
Final
54
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Parramatta
Recruitment hospital [2] 0 0
GSK Investigational Site - Sydney
Recruitment hospital [3] 0 0
GSK Investigational Site - East Melbourne
Recruitment hospital [4] 0 0
GSK Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
2150 - Parramatta
Recruitment postcode(s) [2] 0 0
2000 - Sydney
Recruitment postcode(s) [3] 0 0
3002 - East Melbourne
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
Denmark
State/province [1] 0 0
Glostrup
Country [2] 0 0
Germany
State/province [2] 0 0
Baden-Wuerttemberg
Country [3] 0 0
Germany
State/province [3] 0 0
Nordrhein-Westfalen
Country [4] 0 0
Germany
State/province [4] 0 0
Sachsen
Country [5] 0 0
Italy
State/province [5] 0 0
Lombardia
Country [6] 0 0
Italy
State/province [6] 0 0
Piemonte
Country [7] 0 0
Italy
State/province [7] 0 0
Veneto
Country [8] 0 0
Netherlands
State/province [8] 0 0
Amsterdam
Country [9] 0 0
Netherlands
State/province [9] 0 0
Rotterdam

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to characterize the systemic and ocular safety and tolerability, pharmacokinetics, exploratory efficacy and pharmacodynamics of 3 months of repeat administration of oral darapladib in diabetic macular edema patients with centre involvement.
Trial website
https://clinicaltrials.gov/study/NCT01506895
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01506895